Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076342
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | AB | No | No |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | AB | No | No |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | AB | No | No |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/11/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76342ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/06/2023 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 5MG;6.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 076342 | ANI PHARMS |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 078794 | APOTEX |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 076631 | SANDOZ |
TABLET;ORAL; 10MG;12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 076342 | ANI PHARMS |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 078794 | APOTEX |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 076631 | SANDOZ |
LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | Yes | AB | 020033 | VALIDUS PHARMS |
TABLET;ORAL; 20MG;12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 076342 | ANI PHARMS |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 078794 | APOTEX |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 076631 | SANDOZ |
LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | Yes | AB | 020033 | VALIDUS PHARMS |
TABLET;ORAL; 20MG;25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET;ORAL | Prescription | No | AB | 076342 | ANI PHARMS |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET;ORAL | Prescription | No | AB | 078794 | APOTEX |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET;ORAL | Prescription | No | AB | 076631 | SANDOZ |
LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET;ORAL | Prescription | Yes | AB | 020033 | VALIDUS PHARMS |